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The U.S. Food and Drug Administration (FDA) approved on Thursday Johnson & Johnson’s (NYSE:JNJ) Darzalex Faspro (daratumumab and hyaluronidase-fihj) for a type of blood cancer.
Darzalex Faspro is the first and only approved treatment for high-risk smoldering multiple myeloma (HR-SMM), enabling earlier intervention before the disease progresses to active multiple myeloma.
Smoldering multiple myeloma is an asymptomatic (no signs or symptoms) precursor state of active myeloma.
FDA approval is based on findings from the AQUILA study, which evaluated the efficacy and safety of Darzalex Faspro compared to active monitoring (or “Watch and Wait”) in the largest Phase 3 trial in patients with HR-SMM.
The AQUILA study demonstrated a significant improvement in the primary endpoint of progression-free survival (PFS), with Darzalex Faspro reducing the risk of disease progression to active multiple myeloma or death by 51% compared to active monitoring.
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The Phase 3 AQUILA study showed that after a median follow-up of 65.2 months, 63.1% of patients who received Darzalex Faspro had not progressed to active myeloma at five years (60 months) versus 40.7% in the active monitoring group.
Beyond the primary endpoint of PFS, patients in AQUILA who received Darzalex Faspro saw a higher response rate of 63.4% compared to 2% with active monitoring.
The median time to patients receiving first-line multiple myeloma treatment was delayed for patients receiving Darzalex Faspro compared to active monitoring, with a median time to first treatment of NR vs 50.2 months for the active monitoring group.
On Thursday, the FDA also approved Johnson & Johnson’s Caplyta (lumateperone) as an adjunctive therapy with antidepressants for major depressive disorder (MDD) in adults.
The approval marks the fourth indication for Caplyta, the first and only FDA-approved treatment for bipolar I and II depression in adults, as an adjunctive and monotherapy; also approved for schizophrenia in adults.
The approval is based on results from two Phase 3 trials — Study 501 and 502 — which both met their primary and key secondary endpoints, providing statistically significant and clinically meaningful improvement in depression symptoms compared to an oral antidepressant plus placebo.
JNJ Price Action: Johnson & Johnson stock is down 0.11% at $186.76 at publication on Friday.
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